LOCATION- South East
SALARY- £45,000 - £75,000 per annum (dependent on experience)
We are looking for a Quality Assurance / Regulator Affairs Manager on a permanent basis ideally in the South East UK with experience in the Medical Devices Industry. Your main duty will be to Manage the Quality Management System and oversee the various Regulatory Affairs duties with an ISO13485 environment for a funded medical devices startup.
The Quality Assurance / Regulatory AffairsManager will ideally have the following attributes:
- Qualified in Engineering ideally (NVQ / HNC / HND / Degree or similar) OR Qualified by experience.
- Understanding of ISO13485, MDSAP, MDR, FDA and other governing bodies / regulations
- Previous experience as a Quality or Regulatory Manager within Medical Devices.
- Have previous experience of the auditing process.
- Capable of constructing all technical documents when bringing a new product to market.
- Have excellent communication skills both verbal and written
- Be self-motivated and have a positive attitude
- Good problem-solving skills.
- Experience with medical devices and pharmaceutical – beneficial
- Managing the Quality Management system day to day.
- Liaising with overseas manufacturers / contractors to ensure compliance.
- Communicating with the FDA and other governing bodies.
- Carry out and assist with audits throughout the business
- Ensure procedures are in place and associated documentation is correct.
- Oversee the implementation of an Electronics document management system.
- Write technical documentation for new products being introduced and developed.